Shared Decision Making in Diabetes Prevention for Women With a History of GDM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-12-28

Brief Summary

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Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes. Lifestyle change and metformin are equally effective in preventing diabetes in patients with a history of GDM, so these women should choose a strategy based on their preferences and values, which may vary by race/ethnicity. This proposal will engage 32 women in shared decision making about diabetes prevention.

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Detailed Description

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The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has been minimal. The research team is implementing a shared decision-making (SDM) intervention for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in evidence-based diabetes prevention using an SDM framework. The research team reached the recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the number of projected participants (n=515), including 56% from racial/ethnic minority groups. PRIDE has been highly successful in treatment engagement, as 85% of participants chose either lifestyle change or metformin. Furthermore, among patients who have reached 12-month follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2 lbs. vs. -0.29 lbs., p\<0.001).

PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among minority women and a history of a GDM diagnosis is one of the most significant risk factors for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold. The research team is planning to pilot an SDM intervention for women with a history of GDM. This project would advance a patient-centered approach to increase uptake of both evidence-based diabetes prevention strategies among the subgroup of minority women at the highest risk of progression to T2DM.

In the proposed project, the research team plans to enroll women with a history of GDM in a pilot study, tracking their choice of diabetes prevention strategy and their weight change over time. Importantly, the pilot will enable the research team to estimate the sample size for a future, multi-center study to engage women with a history of GDM in SDM for diabetes prevention. The project's specific aim is as follows:

In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes, with a sample divided equally between whites, African Americans, Latinas and Asian Americans

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Shared decision-making with pharmacists

Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool

Group Type EXPERIMENTAL

Shared decision-making with pharmacists

Intervention Type BEHAVIORAL

Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.

Interventions

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Shared decision-making with pharmacists

Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Overweight or obese (BMI \>25 or \>23 if Asian American)
* at least 6 weeks post-partum
* have a history of gestational diabetes mellitus

Exclusion Criteria

* Currently pregnant,
* not a UCLA Health patient
* any history of a Type 2 diabetes diagnosis, based on billing codes, laboratory values, or taking any antiglycemic medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Kenrik Duru

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Toluca Lake Health Center

Burbank, California, United States

Site Status

100 Medical Plaza Primary Care Suites 455 & 490

Los Angeles, California, United States

Site Status

Internal Medicine Women's Health Clinic Suites 250 & 290

Los Angeles, California, United States

Site Status

UCLA Internal Medicine Family Westwood Suite 465

Los Angeles, California, United States

Site Status

UCLA Internal Medicine Geriatrics Suite 365 & 420

Los Angeles, California, United States

Site Status

CPN Brentwood

Los Angeles, California, United States

Site Status

CPN West Washington Internal Medicine

Los Angeles, California, United States

Site Status